Rectal Balloon Training in Female Urinary Incontinence - Full Text View

Purpose

Urinary incontinence (UI) is a common and worldwide problem.Although pelvic floor muscle training(PFMT) is the standard recommendation for conservative treatment but some patients had difficulty doing PFMT. They could not locate the pelvic floor muscles, and so could not perform the PFMT properly or increase intensity of the exercise. The authors hypothesized that rectal balloon training(RBT) may improve patients' pelvic floor recognition as well as it is another option of progressive strengthening of pelvic floor muscle. This study's aim is to combine RBT with PFMT using the water-filled balloons of Foley catheters

Condition	Intervention	Phase
Urinary Incontinence	Other: Rectal Balloon Training Other: Pelvic floor muscle training (PFMT)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 2B Study of Rectal Ballooning Training in Female Urinary Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Urinary Incontinence

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

Pelvic floor muscle strength [ Time Frame: Change from baseline in pelvic floor muscle strength at 6 weeks ] [ Designated as safety issue: Yes ]
Pelvic floor muscle strength will be assessed by biofeedback and recorded in unit of mmHg.

Secondary Outcome Measures:

Clinical symptoms [ Time Frame: At the first time then 6 weeks later ] [ Designated as safety issue: Yes ]
Clinical symptoms are assessed from questionaire and one-hour pad test

Estimated Enrollment:	60
Study Start Date:	November 2010
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rectal Balloon Training Subjects in combined RBT and PFMT group are taught Foley catheter insertion technique. The catheter is inserted into the rectum until the lower end of the balloon is 1 cm inside from the anus. Then the balloon is blown with clean water. Subjects will contract pelvic floor muscle in standing position by contracting the pelvic floor muscle, hold and count 1 to 5, then relax and count 1 to 5. Subjects are instructed to do the exercise 15 times/set, 3 sets/day, every day for 6 weeks.	Other: Rectal Balloon Training Subjects in combined RBT and PFMT group are taught for foley catheter insertion technique. The catheter is inserted into the rectum until the lower end of the balloon is 1 cm inside from the anus. Then the balloon is blown with clean water starting at 10 cc. Then the volume is progress to 15 cc in 3rd week and 20 cc in 5th week
Active Comparator: Control group Patients receive Pelvic floor muscle training without inserting any kinds of equipment.	Other: Pelvic floor muscle training (PFMT) Standard pelvic floor muscle exercise (Pelvic floor muscle training;PFMT) is assigned for 6 weeks.

Arms

Assigned Interventions

Experimental: Rectal Balloon Training

Subjects in combined RBT and PFMT group are taught Foley catheter insertion technique. The catheter is inserted into the rectum until the lower end of the balloon is 1 cm inside from the anus. Then the balloon is blown with clean water. Subjects will contract pelvic floor muscle in standing position by contracting the pelvic floor muscle, hold and count 1 to 5, then relax and count 1 to 5. Subjects are instructed to do the exercise 15 times/set, 3 sets/day, every day for 6 weeks.

Other: Rectal Balloon Training

Subjects in combined RBT and PFMT group are taught for foley catheter insertion technique. The catheter is inserted into the rectum until the lower end of the balloon is 1 cm inside from the anus. Then the balloon is blown with clean water starting at 10 cc. Then the volume is progress to 15 cc in 3rd week and 20 cc in 5th week

Active Comparator: Control group

Patients receive Pelvic floor muscle training without inserting any kinds of equipment.

Other: Pelvic floor muscle training (PFMT)

Standard pelvic floor muscle exercise (Pelvic floor muscle training;PFMT) is assigned for 6 weeks.

Detailed Description:

This study's aim is to combine RBT with PFMT using the water-filled balloons of Foley catheters. The catheter would be inserted into the rectum and used as a tool to help the patient recognize the pelvic floor muscles. The advantages of Foley catheters are that they are cheap, safe for contacting the mucosa, easy for self-insertion, and can be reused. Furthermore, we can increase the load of exercise by increasing the amount of water pushing into the balloon, and can use that as a tool for progressive resistive exercise.

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female
Age 25 - 70 years
Have urinary incontinence problem
Follow command
Informed consent

Exclusion Criteria:

Previous surgical correction of UI
Use medications for treating overactive bladder symptoms
Impaired recent and/or recall memory
Brain and/or Spinal cord lesion
Untreated Urinary tract infection
Anal lesion which contradicted for inserting instrument
Prolapsed rectum
Prolapsed uterus
History of pelvic injury
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245153

Locations

Thailand
King Chulalongkorn Memorial Hospital	Recruiting
Bangkok, Thailand, 10330
Contact: Nattiya Tantisiriwat 6622564433 rehabcu@gmail.com
Department of Rehabilitation Medicine, King Chualongkorn Memorial Hospital	Recruiting
Bangkok, Thailand, 10330
Contact: Natthiya Tantisiriwat 6622564433 rehabcu@gmail.com

Sponsors and Collaborators

Chulalongkorn University

More Information

Publications:

Sung MS, Hong JY, Choi YH, Baik SH, Yoon H. FES-biofeedback versus intensive pelvic floor muscle exercise for the prevention and treatment of genuine stress incontinence. J Korean Med Sci. 2000 Jun;15(3):303-8.

Bols EM, Berghmans BC, Hendriks EJ, de Bie RA, Melenhorst J, van Gemert WG, Baeten CG. A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study. BMC Public Health. 2007 Dec 20;7:355.

Whitehead WE, Burgio KL, Engel BT. Biofeedback treatment of fecal incontinence in geriatric patients. J Am Geriatr Soc. 1985 May;33(5):320-4.

De Paepe H, Renson C, Van Laecke E, Raes A, Vande Walle J, Hoebeke P. Pelvic-floor therapy and toilet training in young children with dysfunctional voiding and obstipation. BJU Int. 2000 May;85(7):889-93.

Dannecker C, Wolf V, Raab R, Hepp H, Anthuber C. EMG-biofeedback assisted pelvic floor muscle training is an effective therapy of stress urinary or mixed incontinence: a 7-year experience with 390 patients. Arch Gynecol Obstet. 2005 Dec;273(2):93-7. Epub 2005 Jul 6.

Cammu H, Van Nylen M. Pelvic floor exercises versus vaginal weight cones in genuine stress incontinence. Eur J Obstet Gynecol Reprod Biol. 1998 Mar;77(1):89-93.

Bø K, Talseth T, Holme I. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999 Feb 20;318(7182):487-93.

Dumoulin C, Hay-Smith J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD005654. Review.

Bunyavejchevin S. Risk factors of female urinary incontinence and overactive bladder in Thai postmenopausal women. J Med Assoc Thai. 2005 Sep;88 Suppl 4:S119-23.

Sakondhavat C, Choosuwan C, Kaewrudee S, Soontrapa S, Louanka K. Prevalence and risk factors of urinary incontinence in Khon Kaen menopausal women. J Med Assoc Thai. 2007 Dec;90(12):2553-8.

Panugthong P, Chulyamitporn T, Tanapat Y. Prevalence and risk factors of urinary incontinence in Thai menopausal women at Phramongkutklao Hospital. J Med Assoc Thai. 2005 Nov;88 Suppl 3:S25-30.

Manonai J, Poowapirom A, Kittipiboon S, Patrachai S, Udomsubpayakul U, Chittacharoen A. Female urinary incontinence: a cross-sectional study from a Thai rural area. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):321-5. Epub 2005 Sep 24.

Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynaecol Obstet. 2003 Sep;82(3):327-38. Review.

Responsible Party:	Deparment of Rehabilitation Medicine, Faculty of Medicine,, Chulalongkorn university
ClinicalTrials.gov Identifier:	NCT01245153 History of Changes
Other Study ID Numbers:	REHAB_201011
Study First Received:	November 17, 2010
Last Updated:	November 19, 2010
Health Authority:	Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:

Urinary incontinence, Pelvic floor muscle training

Additional relevant MeSH terms:

Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013